Funded and Developed by Novartis Pharmaceuticals UK Ltd.

This leaflet is intended for patients who have been prescribed Cosentyx for

their moderate to severe plaque psoriasis

Getting to know Cosentyx®

(secukinumab)

140683 Consentyx PsO English LP_FF1.indd 1140683 Consentyx PsO English LP_FF1.indd 1 03/07/2020 11:2503/07/2020 11:25

You have been prescribed Cosentyx to treat your moderate-to-severe plaque psoriasis.

This leaflet explains a bit more about your treatment, as well as some information about Your Cosentyx, the service designed to support you while taking your medicine.

The patient information leaflet that comes with your medicine also contains important information that you should read carefully and keep handy for future reference.

Contents

About your treatment ............................................................................................. 3

Taking and storing Cosentyx .......................................................................... 4

Things to be aware of ............................................................................................. 6

Possible side effects ............................................................................................... 8

About the Your Cosentyx service ........................................................ 10

Frequently asked questions ....................................................................... 12

Glossary .............................................................................................................................. 14

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What is Cosentyx and what is it used for?

Cosentyx is what’s known as a ‘biologic’ medicine, for adults with plaque psoriasis. The active part of the medicine is called secukinumab, which belongs to a group of medicines called interleukin (IL) inhibitors. Cosentyx works by neutralising the activity of a protein called IL-17A, which plays an important role in causing inflammation in diseases such as plaque psoriasis.

How long does Cosentyx take to work?

The time taken for Cosentyx to work may vary from person to person. Most people taking Cosentyx will experience improvement within 16 weeks of treatment, but for some it may be sooner.

About your treatment

How do I take Cosentyx?

Cosentyx is given via an injection under your skin (subcutaneous injection). Injections are given using either SensoReady® injection pens or pre-filled syringes. These have been developed to make injection as easy and pain-free as possible.

You and your doctor will decide if you should inject yourself. It is important not to try to inject yourself until you have been trained by your doctor, nurse or pharmacist. A caregiver may also give you your injection after adequate training.

Watch a demonstration of how to inject CosentyxScan code to follow link.

How much Cosentyx is given and for how long?

• The recommended dose is 300 mg by subcutaneous injection

• Each 300 mg dose is given as two injections of 150 mg

Example treatment schedule

Taking and storing Cosentyx

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First dose: Week 0

Week 1

Week 2

Week 3

Week 4etc.+ 1 Month + 1 Month

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«

«

«

«

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Hand rule (first phase = 1 Hand)

In the first phase injections are given on a weekly basis.

From Week 4 injections are given on a monthly basis (maintenance phase).

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After your first dose (Week 0) you will receive further weekly injections at Weeks 1, 2, 3 and 4, followed by monthly injections. At each time point you will receive a 300 mg dose given as two injections of 150 mg.

This is a long-term treatment. You should continue using your medicine even if your symptoms improve. Your doctor will regularly monitor your condition to check that the treatment is having the desired effect.

How should I store my medicine?

Do not use this medicine:

• After the expiry date which is stated on the outer box or the label on the pen after ‘EXP’

• If the liquid contains easily visible particles, is cloudy or is distinctly brown

How to store this medicine:

• Store the pen sealed in its box to protect from light. Store in the refrigerator between 2°C and 8°C. Do not freeze. Do not shake.

This medicine is for single use only. Ask your pharmacist how to dispose of medicines no longer required.

• If necessary, Cosentyx can be left out of the refrigerator on a single occasion for up to 4 days at room temperature, not above 30°C

• Once Cosentyx has been out of the refrigerator for more than 4 days, it cannot be used and should be discarded, not re-refrigerated

Keep this medicine out of the sight and reach of children.

Can I take other medications while being treated with Cosentyx?

Tell your doctor or pharmacist:• if you are taking, have recently taken or might take any other medicines• if you have recently had or are due to have a vaccination. You should not

be given certain type of vaccines (live vaccines) while using this medicine

What should I know before starting treatment?

You should not use Cosentyx:• if you are allergic to secukinumab or any of the

other ingredients listed below: – Histidine – Histidine hydrochloride monohydrate – Polysorbate 80 – Trehalose dihydrate – Methionine

• If you think you may be allergic, ask your doctor for advice before using Cosentyx

• If you have an active infection that your doctor thinks is important

Is there anything I should tell my doctor, nurse or pharmacist before starting treatment?

You should tell your doctor, nurse or pharmacist:• if you currently have an infection • if you have long-term or repeated infections• if you have tuberculosis• if you have Crohn’s disease • if you have ulcerative colitis • if you have recently had a vaccination or if you are due to have a

vaccination during treatment with Cosentyx• if you are receiving any other treatment for psoriasis, such as another

immunosuppressant or phototherapy with ultraviolet (UV) light• if you have a latex allergy

Things to be aware of

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Is there anything I should look out for when on treatment?

Cosentyx can potentially cause serious side effects, including infections and allergic reactions. You must look out for signs of these conditions while you are taking your medicine.

Stop using Cosentyx and tell your doctor or seek medical help immediately if you notice any signs indicating a possible serious infection or an allergic reaction. Such signs are listed on the next page of this booklet and under “Serious side effects” in section 4 of the patient information leaflet included in your Cosentyx injection pack.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects

Stop using Cosentyx and tell your doctor or seek medical help immediately if you get any of the following side effects. Your doctor will decide if and when you may restart the treatment.

Possible serious infection – the signs may include:

• Fever, flu-like symptoms, night sweats• Feeling tired or short of breath, cough which will not go away• Warm, red and painful skin, or a painful skin rash with blisters• Burning sensation when passing urine

Serious allergic reaction – the signs may include:

• Difficulty breathing or swallowing• Low blood pressure, which can cause dizziness or light headedness• Swelling of the face, lips, tongue or throat• Severe itching of the skin, with a red rash or raised bumps

Possible side effects

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Other side effects

Most of the following side effects are mild to moderate. If any of these side effects becomes severe, tell your doctor, pharmacist or nurse.

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Possible side effects and their frequency:

Very common (may affect more than 1 in 10 people)

• Upper respiratory tract infections with symptoms such as sore throat and stuffy nose (nasopharyngitis, rhinitis)

Common (may affect up to 1 in 10 people)

• Cold sores (oral herpes)• Diarrhoea• Runny nose (rhinorrhoea)• Athlete’s foot (tinea pedis)

Uncommon (may affect up to 1 in 100 people)

• Itchy rash (urticaria)• Oral thrush (oral candidiasis)• Signs of low levels of white blood cells, such as fever, sore

throat or mouth ulcers due to infections (neutropenia)• Infection of the external ear (otitis externa)• Discharge from the eye with itching, redness and swelling

(conjunctivitis)• Lower respiratory tract infections• Abdominal cramps and pain, diarrhoea, weight loss or

blood in the stool (signs of bowel problems)

Rare (may affect up to 1 in 1,000 people)

• Severe allergic reaction with shock (anaphylactic reaction)• Redness and shedding of skin over a larger area of the

body, which may be itchy or painful (exfoliative dermatitis)

Frequency not known (frequency cannot be estimated from available data)

• Fungal infections of the skin and mucous membranes (including oesophageal candidiasis).

When you are prescribed Cosentyx, you can benefit from a personalised service, which is designed to support you while taking your medicine.

This includes:

About the Your Cosentyx service

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Contains everything you need to get going with your medicine and to help you get the most out of your treatment

A support line for arranging your Cosentyx deliveries and Homecare nurse visit

You will get Cosentyx SensoReady® pens delivered straight to your door, and a home visit from a Homecare nurse

Your Homecare

Your Cosentyx pack

Your Homecare support line

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What happens once I’m signed up for Your Cosentyx?

• You will be contacted by a member of the Your Homecare team to arrange your first delivery of your medicine at a time that suits you

– The delivery will also include the Your Cosentyx pack, which contains a range of useful information to help you get the most out of your treatment

• You will get a call from a Homecare nurse to decide when you would like to have your home visit

– During this home visit, your nurse will make sure you are comfortable with the self-injection technique and answer any questions you may have

What should I do if I forget an injection?

If you have forgotten to inject a dose of Cosentyx, inject the next dose as soon as you remember. Then talk to your doctor to discuss when you should inject the next dose.

What should I do if I administer a dose before my scheduled injection date?

If you have injected more Cosentyx than you should or the dose has been administered sooner than according to your doctor’s prescription, speak to your doctor as soon as possible.

What should I do if the Cosentyx SensoReady® pen doesn’t work?

If you think your pen is not working correctly or are unsure whether you have correctly injected using the pen, please contact your doctor or pharmacist.

What should I do with Cosentyx SensoReady® pens or pre-filled syringes after my injection?

• Dispose of the used pen or syringe in a sharps disposal container (i.e. a puncture-resistant closable container, or similar)

• Never try to reuse your pen or syringe

• Do not throw away any medicines via waste water. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What should I do if I notice that the liquid in my Cosentyx SensoReady® pen is cloudy?

Do not use Cosentyx SensoReady® if the liquid contains easily visible particles, is cloudy or is distinctly brown.

What should I do if I stop using Cosentyx?

It is not dangerous to stop using Cosentyx. However, if you stop, your symptoms may come back.

Frequently asked questions

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Can I take Cosentyx whilst pregnant/breastfeeding?

It is preferable to avoid the use of Cosentyx in pregnancy. The effects of this medicine in pregnant women are not known. If you are a woman of childbearing potential, you are advised to avoid becoming pregnant and must use adequate contraception while using Cosentyx and for at least 20 weeks after the last Cosentyx dose. Talk to your doctor if you are pregnant, think you may be pregnant or are planning to have a baby.

Talk to your doctor if you are breastfeeding or are planning to breastfeed. You and your doctor should decide if you will breastfeed or use Cosentyx. You should not do both. After using Cosentyx you should not breastfeed for at least 20 weeks after the last dose.

Can I drive or operate machinery whilst taking Cosentyx?

Cosentyx is unlikely to influence your ability to drive and use machines.

What should I do if there is a spot of blood at the injection site?

There may be a small amount of blood at the injection site. You can press a cotton ball or gauze over the injection site and hold it for 10 seconds. Do not rub the injection site. You may cover the injection site with a small adhesive bandage, if needed.

If you have any other questions about Cosentyx, please speak to your doctor, nurse or pharmacist.

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Autoimmune diseaseIn autoimmune diseases, the immune system targets the body’s own components (e.g. cells) by mistake.

Autoimmune diseases are typically treated with medicines that change or dampen the immune response.

Immune systemThe immune system is the body’s own defence system against foreign substances and organisms.

Interleukin-17AInterleukin-17A (IL-17A) is a protein of the immune system, found in increased levels in the skin in conditions like psoriasis.

PlaquesPlaques are red, thickened areas of the skin covered by silver-white flakes and are characteristic of plaque psoriasis. Removing the flakes will reveal red skin underneath and may cause bleeding.

ProteinProteins are important compounds in the body. There are lots of different types of protein, performing a range of roles.

Glossary

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PsoriasisPsoriasis is an autoimmune disease, which primarily affects the skin, but which can also have an effect on fingernails, joints and other organs.

SecukinumabCosentyx is the brand name for secukinumab. Secukinumab is a monoclonal antibody that targets IL-17A.

Subcutaneous injectionSubcutaneous injections are injections that are administered underneath the skin.

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Who to contact in case of side effects, or if you have any questions

For medical advice or side effect questions• For medical advice, or if you get any side effects, talk to your doctor, pharmacist or

nurse. This includes any possible side effects not listed in the patient information leaflet that came in the Cosentyx box

• For questions about your prescription please contact your doctor or pharmacist

• For questions about Your Homecare deliveries please contact Your Homecare support line. Please see the leaflet provided with your patient pack for detail

Contacts for further informationThe Psoriasis Association www.psoriasis-association.org.uk

The Psoriasis and Psoriatic Arthritis Alliance www.papaa.org

SymTrac™ Psoriasis

SymTrac™ Psoriasis is a free app designed to help you track your quality of life and symptoms, helping you better understand the pattern and impact of your psoriasis on your skin, supporting smarter decisions about your care.

SymTrac™ Psoriasis is available for iOS and Android devices. Download it from the App Store or Google Play Store.

SymTrac™ Psoriasis has been designed by Novartis Pharmaceuticals UK Ltd. in partnership with people living with psoriasis.

COS19-C188d Date of preparation: June 2020

Reporting of side effectsIf you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard. Side effects may also be reported to Novartis on 01276 698370 or via medinfo.uk@novartis.com. By reporting side effects you can help provide more information on the safety of this medicine.